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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K162929
Device Name Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
Applicant
Stryker Corporation
Botzinger Strasse 41
Freiburg Baden-Wurttemberg,  DE D-79111
Applicant Contact Brittney M. Larsen
Correspondent
Stryker Corporation
Botzinger Strasse 41
Freiburg Baden-Wurttemberg,  DE D-79111
Correspondent Contact Brittney M. Larsen
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/19/2016
Decision Date 02/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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